CataractNCT03997890
Clinical Outcomes of Patients Bilaterally Implanted With the TECNIS® Symfony or TECNIS® Symfony Toric Extended Range of Vision IOL
A study testing Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs in people with Cataract, run by Yonsei University at 1 site in South Korea.
Trial summary
In With increased patients' demand for a spectacle-free lifestyle and technological advancements, cataract surgery with multifocal intraocular lens (IOL) implantation has become an effective solution for correcting presbyopia in patients who want to maintain their full range of vision. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2016to 18 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age of 20 years or older
- 2. Cataract
Who cannot join
- 1. Amblyopia
- 2. Keratoconus
- 3. Previous corneal or refractive surgery
- 4. Chronic or recurrent uveitis
- 5. Acute ocular disease
- 6. Previous ocular surgeries
- 7. Glaucoma
- 8. Any ocular disease which could possible affect the postoperative visual acuity
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Yonsei Univeristy College of Medicine
Seoul, 03722
About this study
In With increased patients' demand for a spectacle-free lifestyle and technological advancements, cataract surgery with multifocal intraocular lens (IOL) implantation has become an effective solution for correcting presbyopia in patients who want to maintain their full range of vision.
Conventional bifocal IOLs used either refractive or diffractive optics to split the light and create 2 principal focal points, thus providing functional vision at distance and near. This simultaneous imaging principle produces a sharp image that is overlaid by a secondary blurred out-of focus image, so these IOLs inherently produce a deterioration in contrast sensitivity and unwanted photic phenomena such as glare and halos. Additionally, studies reported insufficient intermediate vision with bifocal IOLs.
Read more
There is an increasing desire for spectacle independence at intermediate distance, especially due to the increased use of computers and smartphones. Trifocal IOLs were introduced to the market in 2010 and participants provide an additional, third focal point to improve intermediate vision without compromising distance and near vision. However, participants are still vulnerable to decreased contrast sensitivity and photic phenomena due to the IOL's mechanism of splitting the light into discrete focal points.
An extended depth of focus (EDOF) technology was recently introduced with the aim to improve intermediate vision while maintaining image contrast. The diffractive echelette design, embedded on its posterior optical surface, extends the range of vision and the achromatic technology reduces corneal chromatic aberrations to enhance retinal image quality and improve contrast sensitivity. The elongated focus allows imaging in a continuous range of vision without overlapping near and far images, and therefore theoretically would provide a more consistent distance and intermediate vision with less dysphotopsia.
The aim of this study was to investigate the clinical outcome of patients bilaterally implanted with either Tecnis Symfony or Tecnis Symfony toric extended range of vision IOLs (Johnson \& Johnson Vision, Santa Ana, CA, USA) in terms of visual performance at different distances, spectacle independence, photic phenomena, and patient satisfaction.
Read the detailed description
Enrollment period : 18 months after IRB approval Participants : Patients who had uncomplicated cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs.
Methods: The postoperative examinations were performed at 4-8 weeks, and 4-6 months postoperatively. Binocular corrected (CDVA) and uncorrected (UDVA) distance visual acuity was assessed at 4 m using a Snellen chart. Binocular uncorrected intermediate visual acuity (UIVA) at 70 cm and binocular uncorrected near visual acuity (UNVA) at 40 cm were assessed using the Rosenbaum near vision card.
A subjective questionnaire on spectacle use, photic phenomena, and satisfaction was administered to all patients. Patients were asked how often (never, occasionally, 50% of the time, frequently) participants wear spectacles for near, intermediate, and distance activities. Non-directed and directed questions were used with regard to visual symptoms. Photic phenomena (halos, glare and starbursts) were graded as none, trace, mild, moderate, or severe. Patients were asked to rate their level of satisfaction with distance, intermediate, and near vision on a scale from 0 (completely dissatisfied) to 10 (completely satisfied). Additionally, participants were asked whether participants would choose the same IOL again and if participants would recommend the IOL to their friends and family. Surgeons were also asked to rate their level of satisfaction on a scale from 0 to 10 in terms of the ease of manipulation and implantation of the IOL and the visual performance of the IOL.
- Conditions
- Cataract
- Being tested
- Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs
- Keywords
- Extended depth of focus, Multifocal intraocular lens, Presbyopia, Cataract surgery
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLsProcedure or surgery
After creating an initial side port incision with a 15-degree blade, 3-step clear corneal incisions were made using a 2.5 mm disposable metal blade. Sodium hyaluronate 1.0% (Healon; Abbott Medical Optics) was then injected into the anterior chamber. A continuous curvilinear capsulorrhexis, measuring 5.5 mm in diameter, was generated using a 26 gauge bent needle. After hydrodissection, phacoemulsification was done to remove nuclear fragments and aspiration of residual cortex. In all eyes, a Symfony or Symfony toric IOL was implanted in the capsular bag using a disposable implantation system. Irrigation and aspiration were performed to minimize ophthalmic viscoelastic surgical device retention at the end of surgery. The main incision and side port were sealed with stromal hydration using a balanced salt solution.
| Study group | Role | What they receive |
|---|---|---|
| Symfony group | Experimental | The subjects who underwent cataract surgery with binocular implantation of either Symfony or Symfony toric IOLs Receives: Procedure: Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual outcome
- Uncorrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Measured: preoperative 4-6 weeks
Visual outcome
- Corrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Measured: preoperative 4-6 weeks
Visual outcome
- Uncorrected Intermediate Visual Acuity (70 cm) in logMAR scale at each time point.
Measured: preoperative 4-6 weeks
Visual outcome
- Uncorrected Near Visual Acuity (40 cm) in logMAR scale at each time point.
Measured: preoperative 4-6 weeks
Visual outcome
- Uncorrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Measured: preoperative 4-6 months
Visual outcome
- Corrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Measured: preoperative 4-6 months
Visual outcome
- Uncorrected Intermediate Visual Acuity (70 cm) in logMAR scale at each time point.
Measured: preoperative 4-6 months
Visual outcome
- Uncorrected Near Visual Acuity (40 cm) in logMAR scale at each time point.
Measured: preoperative 4-6 months
Secondary outcomes (6)
Spectacle use
Patients were asked how often (never, occasionally, 50% of the time, frequently) participants wear spectacles for near, intermediate, and distance activities.
Measured: Postoperative 4-6 weeks
Spectacle use
Patients were asked how often (never, occasionally, 50% of the time, frequently) participants wear spectacles for near, intermediate, and distance activities.
Measured: Postoperative 4-6 months
Photic phenomena
Photic phenomena (halos, glare and starbursts) were graded as none, trace, mild, moderate, or severe.
Measured: Postoperative 4-6 weeks
Photic phenomena
Photic phenomena (halos, glare and starbursts) were graded as none, trace, mild, moderate, or severe.
Measured: Postoperative 4-6 months
Patient Satisfaction
Patients were asked to rate their level of satisfaction with distance, intermediate, and near vision on a scale from 0 (completely dissatisfied) to 10 (completely satisfied). Additionally, participants were asked whether participants would choose the same IOL again and if participants would recommend the IOL to their friends and family.
Measured: Postoperative 4-6 weeks
Patient Satisfaction
Patients were asked to rate their level of satisfaction with distance, intermediate, and near vision on a scale from 0 (completely dissatisfied) to 10 (completely satisfied). Additionally, participants were asked whether participants would choose the same IOL again and if participants would recommend the IOL to their friends and family.
Measured: Postoperative 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start13 Jul 2016
- Primary completion18 Jan 2018
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997890
- Sponsor's protocol ID
- 1-2016-0029
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Patients Bilaterally Implanted With the TECNIS® Symfony or TECNIS® Symfony Toric Extended Range of Vision IOL
- ClinicalTrials.gov ID
- NCT03997890
- Acronym / sponsor ID
- 1-2016-0029
- Conditions
- Cataract
- Keywords
- Extended depth of focus, Multifocal intraocular lens, Presbyopia, Cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Jul 2016 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In With increased patients' demand for a spectacle-free lifestyle and technological advancements, cataract surgery with multifocal intraocular lens (IOL) implantation has become an effective solution for correcting presbyopia in patients who want to maintain their full range of vision.
Conventional bifocal IOLs used either refractive or diffractive optics to split the light and create 2 principal focal points, thus providing functional vision at distance and near. This simultaneous imaging principle produces a sharp image that is overlaid by a secondary blurred out-of focus image, so these IOLs inherently produce a deterioration in contrast sensitivity and unwanted photic phenomena such as glare and halos. Additionally, studies reported insufficient intermediate vision with bifocal IOLs.
There is an increasing desire for spectacle independence at intermediate distance, especially due to the increased use of computers and smartphones. Trifocal IOLs were introduced to the market in 2010 and participants provide an additional, third focal point to improve intermediate vision without compromising distance and near vision. However, participants are still vulnerable to decreased contrast sensitivity and photic phenomena due to the IOL's mechanism of splitting the light into discrete focal points.
An extended depth of focus (EDOF) technology was recently introduced with the aim to improve intermediate vision while maintaining image contrast. The diffractive echelette design, embedded on its posterior optical surface, extends the range of vision and the achromatic technology reduces corneal chromatic aberrations to enhance retinal image quality and improve contrast sensitivity. The elongated focus allows imaging in a continuous range of vision without overlapping near and far images, and therefore theoretically would provide a more consistent distance and intermediate vision with less dysphotopsia.
The aim of this study was to investigate the clinical outcome of patients bilaterally implanted with either Tecnis Symfony or Tecnis Symfony toric extended range of vision IOLs (Johnson \& Johnson Vision, Santa Ana, CA, USA) in terms of visual performance at different distances, spectacle independence, photic phenomena, and patient satisfaction.
Detailed description
Enrollment period : 18 months after IRB approval Participants : Patients who had uncomplicated cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs.
Methods: The postoperative examinations were performed at 4-8 weeks, and 4-6 months postoperatively. Binocular corrected (CDVA) and uncorrected (UDVA) distance visual acuity was assessed at 4 m using a Snellen chart. Binocular uncorrected intermediate visual acuity (UIVA) at 70 cm and binocular uncorrected near visual acuity (UNVA) at 40 cm were assessed using the Rosenbaum near vision card.
A subjective questionnaire on spectacle use, photic phenomena, and satisfaction was administered to all patients. Patients were asked how often (never, occasionally, 50% of the time, frequently) participants wear spectacles for near, intermediate, and distance activities. Non-directed and directed questions were used with regard to visual symptoms. Photic phenomena (halos, glare and starbursts) were graded as none, trace, mild, moderate, or severe. Patients were asked to rate their level of satisfaction with distance, intermediate, and near vision on a scale from 0 (completely dissatisfied) to 10 (completely satisfied). Additionally, participants were asked whether participants would choose the same IOL again and if participants would recommend the IOL to their friends and family. Surgeons were also asked to rate their level of satisfaction on a scale from 0 to 10 in terms of the ease of manipulation and implantation of the IOL and the visual performance of the IOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symfony group | Experimental | Procedure: Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLsThe subjects who underwent cataract surgery with binocular implantation of either Symfony or Symfony toric IOLs |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Age of 20 years or older
- 2. Cataract
Key exclusion criteria (8 listed)
- 1. Amblyopia
- 2. Keratoconus
- 3. Previous corneal or refractive surgery
- 4. Chronic or recurrent uveitis
- 5. Acute ocular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLsAfter creating an initial side port incision with a 15-degree blade, 3-step clear corneal incisions were made using a 2.5 mm disposable metal blade. Sodium hyaluronate 1.0% (Healon; Abbott Medical Optics) was then injected into the anterior chamber. A continuous curvilinear capsulorrhexis, measuring 5.5 mm in diameter, was generated using a 26 gauge bent needle. After hydrodissection, phacoemulsification was done to remove nuclear fragments and aspiration of residual cortex. In all eyes, a Symfony or Symfony toric IOL was implanted in the capsular bag using a disposable implantation system. Irrigation and aspiration were performed to minimize ophthalmic viscoelastic surgical device retention at the end of surgery. The main incision and side port were sealed with stromal hydration using a balanced salt solution. | Procedure or surgery | Symfony group |
Primary outcome
Visual outcome
Time frame: preoperative 4-6 weeks
1. Uncorrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Visual outcome
Time frame: preoperative 4-6 weeks
2. Corrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Visual outcome
Time frame: preoperative 4-6 weeks
3. Uncorrected Intermediate Visual Acuity (70 cm) in logMAR scale at each time point.
Visual outcome
Time frame: preoperative 4-6 weeks
4. Uncorrected Near Visual Acuity (40 cm) in logMAR scale at each time point.
Visual outcome
Time frame: preoperative 4-6 months
1. Uncorrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Visual outcome
Time frame: preoperative 4-6 months
2. Corrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Visual outcome
Time frame: preoperative 4-6 months
3. Uncorrected Intermediate Visual Acuity (70 cm) in logMAR scale at each time point.
Visual outcome
Time frame: preoperative 4-6 months
4. Uncorrected Near Visual Acuity (40 cm) in logMAR scale at each time point.
6 secondary outcomes
Spectacle use
Time frame: Postoperative 4-6 weeks
Spectacle use
Time frame: Postoperative 4-6 months
Photic phenomena
Time frame: Postoperative 4-6 weeks
Photic phenomena
Time frame: Postoperative 4-6 months
Patient Satisfaction
Time frame: Postoperative 4-6 weeks
Patient Satisfaction
Time frame: Postoperative 4-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs in people with Cataract, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual outcome (time frame: preoperative 4-6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.